Comparison of ketamine-propofol mixture (ketofol) and midazolam-meperidine in endoscopic retrograde cholangiopancretography (ERCP) for oldest old patients

Figures & data

Figure 1 Distribution of BIS scores of each groups. The y-axis presents BIS level and the x-axis presents the number of patients.

Abbreviation: BIS, bispectral index.

Figure 2 Facial pain score.

Table 1 Demographic characteristics and duration of the procedures

	Group KP (n=75)	Group MM (n=75)	p-value
Age (years)	88.15±3.11	87.99±2.62	0.510^a
Female, n (%)	47 (62.7)	34 (45.3)	0.033^c
Male, n (%)	28 (37.3)	41 (54.7)	0.033^c
BMI	24.16±2.50	24.20±2.28	0.930^b
ASA, n (%)
III	43 (57.3)	41 (54.7)	0.742^c
IV	32 (42.7)	34 (45.3)
Duration of procedures	41.52±13.19	49.15±13.12	0.0001^a
Grade of ERCP procedures
Grade I, n (%)	19 (25.3)	13 (17.3)	0.433^c
Grade II, n (%)	50 (66.7)	57 (76.0)
Grade III, n (%)	6 (8.0)	5 (6.7)

Notes: ^aMann Whitney U-test, ^bIndependent samples t-test, ^cchi-square test.

Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index; ERCP, endoscopic retrograde cholangiopancreatography

Table 2 Diagnosis of the patients

	Group KP (n=75)	Group MM (n=75)	p-value
Indication type
Choledoc stone, n (%)	40 (53.3)	43 (57.3)	0.425^a
Cholangitis, n (%)	21 (28.0)	15 (20.0)
Pancreatitis*, n (%)	6 (8.0)	6 (8.0)
Malignancy, n (%)	5 (6.7)	10 (13.3)
Sepsis, without biliary pathology n (%)
Cholangitis	3 (4.0)	1 (1.3)
Malignancy seconder	3 (4.0)	5 (6.0)	>0.05
Calculi and sludge	18 (24.0)	10 (13)

Note: ^achi-square test.

Table 3 Time-dependent changes in circulatory dynamics, Categorical BIS scores, distribution, and differences between patient groups*

	Group KP (n=75)	Group MM (n=75)	p-value
SBP
T0	148.33±18.83	141.77±22.69	0.056^a
T1	139.96±19.73	114.00±19.73	0.0002^a
T2	136.04±20.45	116.36±20.93	0.0001^a
T3	132.44±19.92	116.31±17.26	0.0001^a
DBP
T0	71.19±12.68	64.21±12.60	0.001^b
T1	62.28±9.55	54.25±11.01	0.0001^b
T2	60.51±7.85	54.11±8.34	0.0001^b
T3	59.91±9.51	52.80±6.03	0.0001^b
HR
T0	70.39±11.10	70.03±11.61	0.846^a
T1	65.49±11.15	70.19±9.14	0.005^a
T2	63.60±8.47	69.59±7.22	0.0001^a
T3	70.36±6.74	74.21±5.04	0.0001^a
SPO2
T0	93.40±2.49	93.00±2.75	0.267^b
T1	92.29±2.09	88.93±2.86	0.0001^b
T2	91.95±1.99	89.60±2.66	0.0001^b
T3	91.79±2.00	90.09±1.66	0.0001^b
T0 BIS score, n (%)
<60	—	4 (5.3)
60–80	73 (97.3)	71 (94.7)	0.015^c
>80	2 (2.7)	—
T1 BIS score, n (%)
<60	5 (6.7)	—
60–80	70 (93.3)	63 (84.0)	0.0001^c
>80	—	12 (16.0)
T2 BIS score, n (%)
<60	5 (6.7)	-
60–80	69 (92.0)	61 (81.3)	0.0001^c
>80	1 (1.3)	14 (18.7)
T3 BIS Score, n (%)
<60	2 (2.7)	—
60–80	72 (96.0)	72 (96.0)	0.148^c
>80	1 (1.3)	3 (4.0)

Notes: ^aIndependent samples t-test, ^bMann Whitney U-test, ^cchi-square with linear likelihood ratio. *Since parameters were compared separately, Bonferroni Correction was not usable.

Abbreviations: BIS, Bispectral index; DBP, Diastolic blood pressure; SBP, Systolic blood pressure.

Figure 3 Distribution of facial pain scores of each group.

Table 4 Ramsay sedation scale

Ramsay sedation scale
1	Patient is anxious and agitated or restless, or both
2	Patient is co-operative, oriented, and tranquil
3	Patient responds to commands only
4	Patient exhibits a brisk response to light glabellar tap or loud auditory stimulus
5	Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
6	Patient exhibits no response

Note: Group MM had significantly higher FPS than Group KP (P<0.0001) (Figures 2 and 3).

Abbreviation: FPS, facial pain score.

Table 5 Time to achieve RSS, MAS, and total dose of rescue medication

Variable	Group KP	Group MM	p-value
Time to RSS 4 (min)	3.21±0.41	5.41±0.49	<0.001
Time to MAS (min)	10.93±0.25	11.11±0.31	<0.001
Total dose of propofol as rescue sedation	10.32±0.62	12.15±0.56	<0.001

Abbreviations: MAS, Modified Aldrete Score; RSS, Ramsay Sedation Score.

Table 6 Sedation related complications during the procedure and the recovery

	Group KP (n=75)	Group MM (n=75)	p-value
Bradycardia, n (%)	2 (2.7)	17 (22.7)	<0.05^a
Apnea, n (%)	3 (4.0)	22 (29.3)	<0.05^a
Hypotension, n (%)	1 (1.3)	3 (4.0)	0.300^a
Desaturation n (%)	9 (12.0)	13 (17.3)	0.356^a
Coughs, n (%)	2 (2.7)	3 (4.0)	0.648
Gagging, n (%)	0 (0.0)	2 (2.7)	0.094
Restraint, n (%)	2 (2.7)	4 (5.3)	0.400
During recovery
Respiratory depression, n (%)	0	0	N/A
Hypotension	3 (4.0)	4 (5.3)	0.698
Bradycardia	1 (1.3)	3 (4.0)	0.300
PONV	4 (5.3)	6 (8.0)	0.513
Apnea	0	0	N/A
Agitation/delirium	3 (4.0)	0	N/A

Note: ^achi-square test.